Job Description

Are you a motivated and innovative engineer looking to make a difference in vaccine manufacturing? As a Senior Specialist, you'll play a critical role in providing technical guidance, leading projects, and driving process improvements that enhance customer satisfaction, safety, and compliance. With a focus on problem-solving, collaboration, and results-driven delivery, you'll be part of a dynamic team that's shaping the future of vaccine production.

The West Point Technical Operations organization is seeking a highly motivated individual for a Senior Specialist - Engineering position for our process engineering team. The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing technical guidance. They will anticipate and interpret customer needs to identify and implement solutions.

Responsibilities include the following:

• Provide technical support for vaccine manufacturing at our Company West Point manufacturing facility.

• Support team safety, environmental, and compliance initiatives.

• Apply technical skills to align activities with department, site and franchise objectives.

• Lead and/or work as a team member on continuous improvement projects, complex manufacturing investigations, process improvement and/or validation projects.

• Complete projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.

• Manage project timelines to ensure key compliance and customer due dates are met; escalating when necessary and developing remediation plans when possible.

• Collaborate with cross functional peers on site and above site as required.

• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve manufacturing challenges.

• Monitor the health of the process through continuous monitoring and the annual process review or continuing validation activities.

• Assure consistent application of standardized work, engineering, and process tools.

• Provide on-the-floor support of complex operational and technical (process/equipment) issues.

• Author and update technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

• Prepare documentation to support regulatory submission and participates in regulatory inspection activities for the facility.

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) degree in Engineering, Sciences, or related field with five (5) years' experience in GMP manufacturing and/or technical support thereof; OR

• Master of Science (M.S.) degree in Engineering, Sciences, or related field with three (3) years' experience in GMP manufacturing and/or technical support thereof

Required Experience and Skills:

• Strong problem-solving skills.

• Experience in biologics, vaccine or bulk sterile manufacturing.

• Developed communication, leadership, and teamwork skills.

• Ability to develop innovative solutions for undefined problems to meet the needs of key stakeholders and project sponsors.

• Ability to manage projects to ensure timely delivery of project milestones.

Preferred Experience and Skills:

• Expertise in cell culture, virology, or industrial microbiology.

• Participation in regulatory inspections.

• Understanding of sterile and aseptic processing.

• Strong understanding of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies/certification.

• Proficient with data analysis and practical statistics.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R328090